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Observational Study of Bicuspid Aortic Valve Competence

This observational study is looking at people with a bicuspid aortic valve (BAV), a common heart condition where the aortic valve has two flaps instead of the usual three. The study uses 4D CTA imaging (a type of CT scan that shows movement) to better understand the normal anatomy of these valves when they are working well. You may be able to join if you are at least 18 years old, have a documented BAV with minimal calcification, and sign a consent form. The study aims to measure the size and shape of the valve's parts over time to help doctors improve BAV repair surgeries. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 60 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo annual 4D CTA scans, routine echocardiograms, and history and physical assessments for five years.
Compensation
Not stated in the trial record.
Follow-up
Your cusp surface areas, cusp height, and cusp free margin length will be measured through study completion, an average of one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04645862

Prospective 4D CTA of BAV Competence

Recruiting
Not specifiedAges 18+Observational
University of Pennsylvania
~60 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:CT scans

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cusp surface areas over the cardiac cycle
Measured over Through study completion, an average of 1 year
+12 more outcomes measured

Conditions

Bicuspid

Explore related trials

Bicuspid Aortic Valve

Where it's being run

1 sites across 1 states
Pennsylvania1

Who to contact

Jessica Nunez
[email protected]
215-829-3712
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

At least 18 years of age
Documented bicuspid aortic valve identified via clinical imaging (e.g., CT, MRI, or echocardiogram) with minimal calcification at the time of enrollment
Participant must sign the informed consent form

Exclusion

Pregnancy (determined by point of care urine pregnancy test)
Renal failure (estimated Glomerular Filtration Rate (eGFR) \< 30), precluding them from receiving intravenous contrast)
Documentation of previous intravenous contrast allergy (unless they are having a CT with steroid preparation as part of routine clinical care)
Previous aortic valve replacement

What this trial measures

  • Cusp surface areas over the cardiac cycleThrough study completion, an average of 1 year

    Surface area of each cusp in mm2 in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.

  • Cusp height (geometric and effective)Through study completion, an average of 1 year

    Geometric and effective cusp height in mm in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.

  • Cusp free margin lengthThrough study completion, an average of 1 year

    Length of the free margin of each cusp in mm in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.

  • Cusp thickness (including raphe thickness, if applicable)Through study completion, an average of 1 year

    Thickness of each cusp in mm in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.

  • Commissural heightThrough study completion, an average of 1 year

    Height of each commissure in mm in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.

  • Sino tubular junction sizeThrough study completion, an average of 1 year

    Diameter of the sinotubular junction in mm in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.

  • Size of the sinuses of ValsalvaThrough study completion, an average of 1 year

    Maximum diameter of the sinuses of Valsalva (mid-level of the aortic root) in mm in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.

  • Ventriculoaortic junction sizeThrough study completion, an average of 1 year

    Diameter of the ventriculoaortic junction in mm in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.

  • Aortic annulus sizeThrough study completion, an average of 1 year

    Diameter of the aortic cusp in mm measured in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.

  • Coaptation height at diastoleThrough study completion, an average of 1 year

    Length of the coaptation zone of the cusps in mm when the valve is closed. This measurement is made in one cardiac cycle (\~0.6 - 1s in length) from the CT image.

  • Cusp displacement over the cardiac cycleThrough study completion, an average of 1 year

    Total displacement of the center of the free margin of each cusp in mm during one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.

  • Cusp velocity over the cardiac cycleThrough study completion, an average of 1 year

    Maximum velocity of the center of the free margin of each cusp in mm/s during one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.

  • Size of the ascending aortaThrough study completion, an average of 1 year

    Maximum diameter of the ascending aorta in cm during one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.